SAN DIEGO and SILVER SPRING, Md.—The U.S. Food and Drug Administration (FDA) authorized today the marketing of the t:slim X2 insulin pump with Control-IQ Technology, an interoperable automated glycemic controller device that automatically adjusts insulin delivery to a person with diabetes by connecting to an alternate controller-enabled insulin pump (ACE pump) and integrated continuous glucose monitor (iCGM). The marketing authorization of the Control-IQ Technology controller was granted to Tandem Diabetes Care Inc.

“With this clearance, we will be launching the most advanced automated insulin dosing system commercially available in the world today. This is a testament to our commitment to improving the lives of people with diabetes by offering simple-to-use products that deliver superior performance,” said John Sheridan, president and CEO of Tandem Diabetes Care.

The Control-IQ Technology controller is a new type of glycemic controller that, when used as a system with compatible iCGMs and ACE pumps, can be used by patients with type 1 diabetes to automatically increase, decrease and suspend delivery of basal insulin based on insulin delivery history, iCGM readings and predicted glucose values. It requires no fingersticks for calibration or diabetes treatment decisions. The controller can also automatically deliver a specific amount of insulin when the glucose value is predicted to exceed a predefined amount. This is also the first such controller that can be used with other diabetes devices designed to be integrated into a customizable diabetes management system for automated insulin delivery.

This FDA authorization paves the way for iCGMs and ACE pumps to be used with an interoperable automated glycemic controller as a complete automated insulin dosing (AID) system. AID systems typically consist of a pump, CGM and software to control the system of compatible devices.

Other software to automatically control insulin delivery has previously been approved by the FDA as part of a single, predefined diabetes management system (as a class III, high-risk device). The Control-IQ Technology controller, which is designed to communicate with other compatible diabetes device components that are also designed to be integrated into a modular system, was reviewed through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type.

The FDA is establishing special controls criteria which outline specific regulatory requirements that, when met along with general controls, provide a reasonable assurance of device safety and effectiveness for devices of this type. For this device, those controls include requirements related to reliability, device interoperability, cybersecurity and clinical relevance.

“Today's action continues the agency’s ongoing efforts to work with the diabetes community to help ensure the safety and efficacy of innovative and customizable diabetes management systems that may help patients better tailor their treatments to their individual needs,” stated Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “The marketing authorization of this first stand-alone interoperable automated glycemic controller also allows substantially equivalent controller technologies that are developed for diabetes in the future to go through the 510(k) review process, helping to promote timely patient access to innovative technologies that can improve their care and quality of life.”

The FDA reviewed data from a clinical trial of the Control-IQ Technology controller that included 168 participants with type 1 diabetes. Patients were randomized to use either the Control-IQ Technology controller installed on a Tandem t:slim X2 insulin pump, or a CGM and insulin pump without the Control-IQ Technology controller. The study demonstrated that the controller determines and commands safe and effective insulin delivery from a compatible ACE pump based on iCGM readings, with limited user intervention outside of mealtimes. The FDA also assessed the ability of the controller to communicate with all parts of the system with appropriate reliability, cybersecurity and fail-safe modes.

“Not only do new closed-loop systems need to be effective at improving glycemic control, they must also be easy to understand and use so patients can experience the full benefits of the technology. The t:slim X2 insulin pump with Control-IQ technology successfully achieved both objectives in the clinical studies,” added Boris Kovatchev, Ph.D., director of the Center for Diabetes Technology at the University of Virginia and principal investigator of the International Diabetes Closed Loop (iDCL) trials. “We are very proud of the extensive academic research that went into this effort, and we are thrilled to see this work has translated into an FDA-cleared device for clinical use so that more people can experience the benefits of this technology.”

Even though the system has been assessed for reliability, incorrect and inappropriate calculation, and command, delay of insulin delivery can still occur. Other risks associated with use of the interoperable controller can include incorrect insulin delivery as a result of loss of communication between connected devices, or from exploitation of cybersecurity vulnerabilities. These associated risks can lead to hypoglycemia or hyperglycemia, including diabetic ketoacidosis.

According to Tandem Diabetes Care, all in-warranty t:slim X2 pump users in the U.S. will have the option to add the new feature free of charge via remote software update. The update is expected to be available by the end of January 2020, and new pumps with Control-IQ technology will begin shipping to customers in the same timeframe.

“The approval of the Control-IQ system with Dexcom G6 CGM brings together two incredible products to deliver a powerful automated insulin dosing solution for people with diabetes,” noted Kevin Sayer, president and CEO of Dexcom. “Sensor accuracy is a critical component for automated insulin dosing, and we are excited that Dexcom G6 users can benefit from our collaborative effort to integrate this advanced hybrid closed loop system.”